# Reduction of bloodstream infections from oral organisms in pediatric stem cell transplant: a randomized multicenter double-blind placebo-controlled study evaluating twice daily oral xylitol

> **NIH NIH UH3** · CINCINNATI CHILDRENS HOSP MED CTR · 2024 · $516,967

## Abstract

Abstract
Bloodstream infections (BSI) caused by bacteria translocating across injured mucosa are a significant cause of
morbidity and mortality in the 25,000 patients undergoing stem cell transplantation (SCT) in the United States
each year. BSI secondary to translocation of oral organisms through damaged oral mucosaoccurs in nearly 16%
of SCT recipients in the first three weeks after SCT despite current routine oral care. There are currently no
known strategies to prevent post-SCT BSI from the translocation of bacteria through an injured mucosa. There
is a critical need to identify preventive strategies to reduce BSI, and the oral mucosa as a specific route of entry
has not been evaluated. In the absence of such information, SCT patients will continue to develop BSI from
translocation of bacteria from mucosal barrier injury. Our long-term goal is to develop and disseminate clinically
relevant and easily adoptable strategies to prevent BSI and improve outcomes after SCT. The overall objective
of this proposal is to identify a clinically effective strategy to prevent or reduce BSI secondary to bacterial
translocation through injured mucosa in the mouth. The rationale for the study is based on our baseline and pilot
intervention data. The central hypothesis is that dental xylitol use, in addition to current oral care practice, are
effective at reducing BSI from oral organisms, and decreasing the incidence of gingivitis, oral plaque, and oral
ulcerations after SCT. Apart from our preliminary data, we are well-positioned to carry out the proposed work
as we have a multicenter collaborative team consisting of pediatric bone marrow transplant physicians, dentists,
and infectious disease specialists with focus and expertise in microbiome analyses. The following specific aims
are proposed: AIM 1: Determine the effectiveness of twice-daily xylitol-wipe application on reducing BSI from
oral organisms through a randomized, multicenter, double-blind, placebo-controlled study in pediatric SCT
recipients. AIM 2: Determine the effectiveness of twice-daily xylitol-wipe application in reducing dental plaque,
mucositis, oral GVHD, and gingival inflammation. AIM 3: Evaluate the influence of twice-daily xylitol-wipe
application on oral microbiome diversity and saliva levels of pathogenic microbial species. The innovation of this
proposal lies in the simplicity and affordability of the intervention. Xylitol is commercially available, inexpensive
($0.15 per application), non-toxic, and can be rapidly adopted into practice. If our hypotheses are proven, xylitol
application could reduce the morbidity and mortality associated with BSI and decrease healthcare-associated
costs of an estimated $40,000 per infection. At the successful completion of the proposed research, our
expectation is to have demonstrated a significant reduction of bacteremia from oral organisms (Aim 1);
decreased oral dental plaque, gingivitis, and oral ulceration (Aim 2); and preserved oral microbiome...

## Key facts

- **NIH application ID:** 10894101
- **Project number:** 5UH3DE030401-04
- **Recipient organization:** CINCINNATI CHILDRENS HOSP MED CTR
- **Principal Investigator:** Christopher Eugene Dandoy
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $516,967
- **Award type:** 5
- **Project period:** 2022-09-01 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10894101

## Citation

> US National Institutes of Health, RePORTER application 10894101, Reduction of bloodstream infections from oral organisms in pediatric stem cell transplant: a randomized multicenter double-blind placebo-controlled study evaluating twice daily oral xylitol (5UH3DE030401-04). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10894101. Licensed CC0.

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